Medtronic recalls thousands of surgical devices due to contamination risk
Medtronic is recalling more than 18,000 surgical devices due to a risk of contamination. The recall includes certain lots of the company’s Gundry and DLP retrograde cannulae, which are cardiopulmonary bypass vascular catheters used to perform open heart surgeries.
This recall was put in place due to the potential of a sterile barrier breach. Only certain lots of these devices are included in the recall.
The U.S. Food and Drug Administration (FDA) has ruled this as a Class II recall. This means the agency believes these devices could cause “temporary or medically reversible adverse health consequences.”
What medical devices are being recalled?
This Class II recall includes:
- GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T—3,790 units
- GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94115T—6,572 units
- DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94215T—600 units
- DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94665—840 units
- DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94965—260 units
- DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913—3,210 units
- DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913L—481 units
- DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94915—280 units
- DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94725—2,620 units
These devices were distributed to customers worldwide, including the United States, Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Cyprus, Denmark, France, Germany, Hong Kong, Hungary, Italy, Japan, Latvia, Lithuania, Malaysia, Moldova, Republic Of, Morocco, Netherlands, Norway, Panama, Poland, Russia, Serbia, Singapore, South Africa, South Korea, Spain, Suriname, Sweden, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay and Vietnam.
Medtronic's GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T. Image courtesy of Medtronic.
What should customers do?
Medtronic’s cardiac surgery division first warned customers about this safety concern on April 21, asking them to contact a customer service number and return any affected product. Customers are also asked to spread the word about this issue if the devices were forwarded to another facility at any time.
Click here for additional information from the FDA.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.